Archive for April, 2011

Putting the Cart Before the Horse when Leading a Test to Market

April 28th, 2011
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Berkeley HeartLab’s experience with its KIF6 StatinCheckTM highlights the discrepancies between how well a test is marketed versus its clinical utility.
In 2008, the assay KIF6 StatinCheck genotype test was introduced as a laboratory developed test.  More than 250,000 tests, with a price tag of about $100 each, have now been performed. In December of 2010, Celera (Berkeley HeartLab’s parent company) submitted a pre-market approval application to the U.S. Food & Drug Administration (FDA) based on several studies. These studies suggested a relationship between carriers of the KIF6 gene and an increased risk of coronary heart disease (CHD) and statin response.
TheBerkeleyHeartLab states the test’s clinical value on its website as follows:
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Health Tech: Economics Can Play an Unusual Role in Entrance to Market

April 21st, 2011
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Entrance-to-market is always a challenging process in the bio-med industry, but where one would normally consider product quality and peer assessment as lead indicators of success, it can be something quite different and unexpected that affects rapid market adoption—such as simple profit-based economics. This is a lesson learned by the San-Francisco-based company XDx, Inc. (Expression Diagnostics) in conjunction with the launch of its diagnostics test Allomap®.
XDx’s Vice President of Corporate Development and Legal Affairs Matthew J. Meyer recently presented at the 3rd Annual Personalized Medicine Partnerships Conference in Bethesda, Maryland. Here, I recap some of the highlights of Meyer’s case study presentation and then offer some insights from Ken Walz, one of the founder’s of Popper and Company.
According to Meyer, the heart transplantation market in the U.S. encompasses nearly 140 centers performing more than 2,000 transplants per year. With the average cost of the procedure at around $750K and topping out at nearly $1M when post-transplant therapy and care is included, the industry fully supports a growing $2B impact on the U.S. healthcare system. Transplant patients and hospital institutions not only face substantial costs in upfront care, but the patient must also pay for and endure between 20 and 35 painful biopsies in an attempt to reduce rejection and minimize immunosuppression.
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Empowering Medical Consumers through a New Age of Partnerships

April 15th, 2011
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In the earlier days of the Internet, the consumer of medical or health-related information was a lone traveler, wandering through dark alleys of information often with little more than intuition and guesswork to guide the way. Who knew what type of foul play lurked in those unregulated shadows?
Interestingly, it isn’t watchdog regulation that’s lighting the path for the lost consumer of medical information today; it’s exciting partnerships around transparent technologies and practices that are seizing the market. For example, we recently participated in the 3rd Annual Personalized Medicine Partnerships Conference, which was designed to shed light on issues of paramount importance to the future of personalized medicine, including partnerships, clinical utility/validation, and the commercial realities of personalized medicine in the global healthcare marketplace. More to come from that conference in future posts…

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Tapping Personalized Health Care’s Potential

April 6th, 2011
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“Translating the knowledge we are gaining from gene discoveries into practical clinical and public health applications will be critical for realizing the potential of personalized health care and improving the health of the nation.”
— Muin J. Khoury, M.D., Ph.D., Director, Office of Public Health Genomics, Centers for Disease Control & Prevention
There are several interesting and exciting developments in personalized health that extend well beyond clinical medicine and into areas of science, ethics, government policy and regulation, patient advocacy, and business.   In January of this year, the Ewing Marion Kauffman Foundation published The Personalized Health Project—Identifying the gaps between discovery and application in the life sciences, and proposed solutions. This report provides insights from key thought leaders as to how far we have come, where there are gaps and barriers, and how far away we are from reaching the goal of implementing personalized health care solutions.
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